Bimekizumab Shows Symptom Improvements in Phase 3 Trials
axSpA patients reported reduced inflammation and better physical function
One year of UCB Biopharm‘s investigational therapy bimekizumab, administered subcutaneously (under the skin) once every four weeks, resulted in sustained improvement in the signs and symptoms of axial spondyloarthritis (axSpA), according to late-breaking data from two BE MOBILE Phase 3 clinical trials.
axSpA is a type of inflammatory arthritis that affects the joints of the spine, pelvis, and chest. Ankylosing spondylitis (AS) is a severe type of axSpA, marked by inflammation of the sacroiliac joints, where the base of the spine joins the pelvis.
Improvements included reduced inflammation, and better physical function and quality of life, regardless of previous treatment with medications that block TNF, a pro-inflammatory signaling protein.
“Results presented today from BE MOBILE 1 and BE MOBILE 2 demonstrate that treatment with bimekizumab provided consistent and sustained improvements to one year in key signs and symptoms across the full spectrum of axial spondyloarthritis, with similar outcomes regardless of previous treatment with TNF inhibitors,” Xenofon Baraliakos, MD, PhD, at Ruhr-University Bochum in Germany, said in a press release.
Bimekizumab clinical trial results
Bimekizumab is an antibody-based therapy designed to block the activity of interleukin (IL)-17A and IL-17F, two immune signaling proteins that drive inflammation. The treatment is approved for certain types of psoriasis, a skin disease marked by red and irritated skin patches.
Data from a previous Phase 2b trial showed bimekizumab provided sustained efficacy over 48 weeks in AS, based on disease benchmarks from the Assessment in SpondyloArthritis International Society (ASAS).
BE MOBILE 1 (NCT03928704) enrolled adults with nonradiographic axSpA (nr-axSpA), a subtype of axSpA, of whom 128 were randomly assigned 160 mg of bimekizumab, and 126 were given a placebo, every four weeks.
BE MOBILE 2 (NCT03928743) tested the therapy in AS patients, of whom 221 were randomized to receive bimekizumab and 111 a placebo.
In both trials, patients initially given to placebo were switched to bimekizumab at week 16. One full year of treatment was completed by 86.6% of nr-axSpA and 89.8% of AS patients.
After one year of continuous bimekizumab treatment, 60.9% of nr-axSpA BE MOBILE 1 participants and 58.4% of AS patients in BE MOBILE 2, achieved an ASAS40 — the percentage of participants who achieved a 40% response rate based on ASAS.
Data were consistent in patients who had not been treated with TNF blockers or those who failed to respond to these medications.
Low disease activity, defined by an ankylosing spondylitis disease activity score (ASDAS) less than 2.1, was achieved in 61.6% of nr-axSpA cases and 57.1% of AS patients at one year. Inactive disease or clinical remission, an ASDAS less than 1.3, was achieved by 25.2% of nr-axSpA and 23.4% of AS patients.
Across both patient groups, there were fewer signs of inflammation, as measured objectively by MRI and C-reactive protein (CRP) after one year of bimekizumab. Improvements in physical function, assessed by the Bath AS functional index (BASFI), and quality of life, by AS quality of life (ASQoL), were also sustained over one year.
“These positive results are the first Phase 3 data evaluating a dual IL-17A and IL-17F inhibitor, bimekizumab, in the long-term treatment of patients living with non-radiographic axial spondyloarthritis and ankylosing spondylitis,” added Baraliakos.
Regarding safety, 75.0% of nr-axSpA and 75.5% of AS patients experienced one or more treatment-emergent adverse events (TEAE). TEAEs included the common cold (nr-axSpA: 12.3%, AS: 9.1%), throat and nose infection (nr-axSpA: 9.4%, AS: 6.4%), and oral thrush (nr-axSpA: 7.4%, AS: 6.1%). COVID-19 infections also were reported (nr-axSpA: 7.0%, AS: 2.1%). The occurrence of serious TEAEs was low (nr-axSpA: 4.4%, AS: 7.1%).
Bimekizumab also showed sustained efficacy in a third Phase 3 clinical trial called BE OPTIMAL (NCT03895203), testing bimekizumab in 852 adults with active psoriatic arthritis (PsA), a condition characterized by psoriasis combined with inflammation, mainly of the hand and feet joints.
“The 52-week data shared today demonstrate the high thresholds of disease control that were achieved by the majority of patients across these three studies,” said Emmanuel Caeymaex, executive vice president at UCB. “The results build on the previously announced 24-week data and show that bimekizumab sustained a clinically meaningful impact for patients through one year.”
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